Industry Insights

The global medical device complaint management market size was estimated at USD 5.37 billion in 2017. It is anticipated to register a CAGR of 7.6% during the forecast period. The transition from paper-based to the digital system for tracking complaints is anticipated to propel the growth. Also, supportive government reforms along with increasing demand for automated system for process of complaint management is expected to further fuel the market expansion in near future.

Incorporation of software aids in improved documentation. By means of a multi-page electronic form that ensures precise capturing of complaint data, the solution reorganizes the documentation part of complaint management system into a simple three-step process that includes processing the complaint, investigation, and complaint resolution. Each step of the process is computerized and documented. The complaint management solution provides advanced analytics along with reporting tools for augmented management oversight. This enhanced transparency improves decision making during the customer complaint management system.

Many companies are also coming up with the mobile application solutions to manage customer complaints. For instance, Intellect provides mobile application platform to their customers for registering complaints, ticket escalation, and query generation. Intellect provides native mobile apps available on the Google Play Store and the App Store that can be downloaded as a custom branded mobile app or an Intellect app.

The U.S. FDA encourages consumers, caregivers, patients, and healthcare professionals to give voluntary reports of important adverse events, and/or product issues to MedWatch that is the FDA’s Safety Information and Adverse Event Reporting Program or by means of the mobile app known as MedWatcher. Furthermore, introduction of MedWatcher is boosting the adverse events reporting. The app radically simplifies and accelerates the process of reporting a complaint by providing users with a four-step form that is submitted electronically to the FDA. Thus, the introduction of such mobile apps for managing the complaints is anticipated to drive the growth of the medical device complaint management market.

Service Insights

The product surveillance and regulatory compliance services segment accounted for the largest market share in 2017. This growth can be attributed to the fact that the regulatory agencies and users of medical devices are becoming less tolerant with the failure of the medical devices as it results in the serious injury, death or potential harm to the users. Also, the regulatory agencies are placing greater emphasis on product surveillance to track product performance and manage compliance.

In product surveillance segment, medical device vigilance/medical device reporting is anticipated to showcase the fastest growth through the forecast period. The growth can be attributed to the fact that the U.S. FDA makes it mandatory for the firms that have received complaints of serious injuries or deaths related to the medical devices, and device malfunction to notify the incident. Any non-compliance of the regulatory requirement may result in a hefty fine for each day.

The complaint log/intake segment is anticipated to showcase a robust growth over the forecast period. As it is the initial stage of managing the complaints and are a gateway mechanism for corrective action/preventive action and post-market activities. Complaint files are also linked to a Medical Device Reporting (MDR) event file because a complaint must be assessed to determine if it is a reportable adverse event. Furthermore, it is mandatory for the medical device manufacturers to record and track customer complaints as per the quality system regulation (QSR) defined in 21 CFR Part 820.

Regional Insights

North America led the market in 2017 and is projected to remain dominant through the forecast period. Stringent regulatory requirements regarding complaint handling and management is driving the regional growth. For instance, in U.S., the regulation of MDR comprises of mandatory requirements for user facilities, manufacturers, and importers to report certain device-related adverse events and problems related to products to the FDA.

Europe is projected to expand at the fastest CAGR throughout the forecast period. The Europe market is strictly regulated and it is mandatory for the medical device manufacturers to report incidents and Field Safety Corrective Actions (FSCA) to the European competent authorities. Manufacturers that fail to report the incidents could face severe consequences.

Asia Pacific is also anticipated to register robust growth over the forecast period. This is due to the fact that major MNCs such as Tata Consultancy Services (TCS) and Wipro have their operating offices in India, driving the regional growth.

Medical Device Complaint Management Market Share Insights

The global market is highly competitive. Some of the key players include Tata Consulting Services (TCS), IQVIA, Biovia, Wipro, Sparta Systems, AssurX, Freyr, SAS, Parexel International Corporation, andMasterControl. These players are frequently engaging in business strategies, such as partnerships and mergers and acquisitions to retain their market share and to diversify their product portfolio.

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Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2014 to 2026. For the purpose of this study, Grand View Research has segmented the global medical device complaint management market report on the basis of service and region: